Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

Severe COVID-19 Disease Clinical Trial

— PC-COVID-HCM  

Official title:

Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542967
• Other study ID #: 047/2020
• Status: Completed
• Phase: Phase 2
• Start date: June 23, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Hospital Central Militar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.

Description:

A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 30, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• O2 saturation <93%

• Radiographic evidence of moderate pneumonia according to Rale's classification.

• Acute respiratory distress syndrome (PaO2 / FiO2 <300 or SpO2 / FiO2 = 315)

• Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)

Exclusion Criteria:

• Pregnant patients

• History of transfusion reactions

• Patients with congestive heart failure

• Patients with a history of chronic kidney failure on dialysis

• Patients with multiple organ failure

• Patients who does not accept or agree with the treatment.

Related Conditions & MeSH terms

• Severe COVID-19 Disease

Intervention

Biological:
• Biological
An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses. If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.

Locations

Country	Name	City	State
Mexico	Hospital Central Militar	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central Militar

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory biomarkers (D dimer)	Change in pro-inflammatory biomarkers (D dimer µg/l)	10 days
Other	Inflammatory biomarkers (Ferritin)	Change in pro-inflammatory biomarkers ( Ferritin µg/L )	10 days
Other	Inflammatory biomarkers (CPR)	Change in pro-inflammatory biomarkers, C-reactive protein ( CPR mg/L )	10 days
Other	Inflammatory biomarkers (LDH)	Change in pro-inflammatory biomarkers, lactate dehydrogenase ( LDH UI/L)	10 days
Primary	Disease progression	Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization	Up to 30 days later from study entry
Primary	Side effects	Side effects associated with the administration of convalescent plasma	Up to 30 days later from study entry
Primary	Mortality	Any cause of death	Up to 30 days later from study entry
Secondary	Respiratory improvement	Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)	10 days
Secondary	Clinical improvement	Change in oxygen saturation levels	10 days
Secondary	Acute adverse events (AAE)	Transfusion reactions during transfusion.	After receiving intervention, an average time one hour, until 24 hours after administration.

External Links

•   Clinical Characteristics of Coronavirus Disease 2019 in China
•   Potential interventions for novel coronavirus in China: A systematic review
•   Use of convalescent plasma therapy in SARS patients in Hong Kong